Translations
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Quorum's Translation Services
As part of Quorum Review IRB’s dedication to enhancing the clinical research process and providing our customers with world-class service, we offer a comprehensive range of translation services. These services provide customers with new and competitive options for their translation needs. As required by applicable federal regulations, informed consent forms must be written in a language that is understandable by the research participant (or his/her legally authorized representative). In addition, other materials provided to non-English speaking participants, including diaries, questionnaires, and recruitment materials, must also be translated into the native language of the non-English speaking participant.Quorum supports the translations of informed consent forms and other study-related documents in over 100 languages and dialects. Our in-house translators are also trained in participant protection and regulatory requirements for human subject protection. If you select Quorum to manage your translations in addition to reviewing your study, Quorum can assure that quality standards are met and that the translations are completed timely. By choosing Quorum, you can also save valuable time by eliminating the need to coordinating with outside translations vendors.
Quorum offers many options for the translation of study-related documents. Each service is designed to satisfy the needs of your study at different stages.
- Standard Forward-Translation Services
- Quorum can assist you with the translation process after the finalization and approval of the English consent form and other English study-related documents. The translation process begins once the English version is approved by the customer and Quorum and/or when the customer requests the translation.
- NEW Fast-Track Translations Service for Consent Forms
- A customer can choose to have consent forms translated on an expedited basis so they are completed 72 hours after the English language consent form is approved by the Board. Quorum Review IRB also provides certifications for fast track translations. The fast track option is available only for the initial translation of a consent form and if requested during the study submission process.
- Standard Back-Translation Services
- Quorum can assist you with the back-translation of an already translated document performed by an outside vendor not authorized by Quorum. This is done so that the Board can compare the back-translation to the English original before approving the translated version.
- NEW Translation Comparison Model
- Quorum can process translated documents by a vendor not authorized by Quorum by comparing them to the original, Quorum-approved English version. If the translation is acceptable, Quorum issues a certification of proofreading. A translation comparison can be completed much more quickly than a traditional back-translation. Standard turnaround times are reduced by almost half.
Q. When is a translation needed? >>
If a sponsor or site anticipates a non-English speaking population will participate in a Quorum Review IRB approved protocol, then translation of the informed consent document and participant recruitment material(s) into the populations’ native language is required. This requirement is in compliance with applicable regulations which state that an informed consent document should be in understandable language to the subject (or authorized representative). Also, before a site requests translation of study documents, the site must confirm that the sponsor/protocol allows enrollment of non-English speaking participants.
Q. Why does Quorum Review IRB require back-translation or comparison translation of a translated document, even when I submit the certification to Quorum Review IRB? >>
Translations provided by the sponsor must be independently reviewed by Quorum Review IRB for accuracy by comparing the English and translated document, known as “back-translation” or “comparison translation.” By doing a back-translation or comparison translation we can ensure the translated materials match our most recent approved (English language) documents for the study.
Q. How do I request to have Quorum coordinate a translation? >>
For sponsor/CRO contacts and single sites, on studies that have not yet been submitted to Quorum, you may request translation by indicating that you would like translations arranged by Quorum in the Central Study Questionnaire, Single Site Study Questionnaire, or Principal Investigator Generated Study Questionnaire. There are various options for when you prefer that we begin the translation project. Please contact our Initial Study Support team to obtain information with questions on completing this form. If you have already submitted to Quorum you can update your translation preferences by submitting a Change Request Form for Sites.
For central study site contacts, please contact your sponsor to request that they contact Quorum to request to have translations be coordinated for the study. Additionally, you will need to indicate on your Site Information Questionnaire that you will be enrolling non-English speaking participants. If you have already submitted to Quorum you may submit a Site Information Change Request Form to request translations.
For central study site contacts, please contact your sponsor to request that they contact Quorum to request to have translations be coordinated for the study. Additionally, you will need to indicate on your Site Information Questionnaire that you will be enrolling non-English speaking participants. If you have already submitted to Quorum you may submit a Site Information Change Request Form to request translations.
Q. How do I obtain a list of Quorum-approved translation vendors? >>
For studies that have not yet been submitted to Quorum, please contact our Initial Study Support team to obtain information on approved translation vendors. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com. If your study has been submitted to Quorum, please contact your Study Manager at (206) 448-4082 or by email to obtain information on approved translation vendors.
Q. I don’t have a staff member fluent in a participant’s language, but I plan to enroll non-English speaking participants. Can their family do the translation? >>
In order to enroll non-English speaking participants there must a non-family member, available on site, who is fluent in the participant’s native language in order to assist in the consenting process.
Q. How does Quorum bill for translations? >>
Quorum and Quorum-approved vendors take into a consideration many factors in the billing process. For translation projects, Quorum will charge per word fees, discounted per word fees for similar segments previously translated, and/or hourly fees in depending on the translation project. Additionally, Quorum has a standard handling fee that applies to all translations. Quorum keeps up with the translation industry standards and stays competitive in the pricing of the translations. If you would like to have quote for a specific project, contact your Study Manager or Quorum’s Initial Study Support team. If you have questions on how a specific project was billed, please forward the question to your Study Manager and he/she will contact the appropriate individual.
Q. Our company has a preferred provider that we use for translations. Can I get them authorized as a “Quorum-approved” translator?" >>
If a customer would like to use their own vendor to complete translated study documents, please contact Quorum for how to get your vendor approved. Please contact InitialStudySupport@quorumreview.com or your Study Manager.
